Kenneth Block

FDA Filings

This page includes the latest FDA filings for Kenneth Block. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number1000487132
FEI Number1000487132
NameKenneth Block
Owner & OperatorOEM SYSTEMS CO. LTD.
Contact Address84 MEKAWA MAKISHIMA-CHO
UJI-SHI KYOTO JP-NOTA 6110041 JP
Official Correspondent
  • Kenneth Block
  • 81-774-202481-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address800 E Campbell Rd Suite 202
Richardson, TX 75081 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number3010772972
FEI Number3010772972
NameKenneth Block
Owner & OperatorSHI-ATEX Co.,Ltd
Contact Address5-3 Ozushima-cho
Izumiotsu JP-27 Osaka 5950074 JP
Official Correspondent
  • TSUYOSHI ISHIBASHI
  • 81-725-201005-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address800 E. Campbell Rd. Suite 202
Richardson, TX 75081 US
Establishment TypeSterilize Medical Device for Another Party (Contract Sterilizer)



FDA Filings

Device
Company
DeviceDate
Kenneth Block [OEM SYSTEMS CO. LTD.]
T-TAS 01 Total Thrombus Formation Analysis System Instrument2020-03-16
Kenneth Block [SHI-ATEX Co.,Ltd]
SMTube2018-08-31
Kenneth Block [OEM SYSTEMS CO. LTD.]
VARIANTnbs Newborn Screening System2016-02-05
Kenneth Block [OEM SYSTEMS CO. LTD.]
VARIANT II TURBO Link2016-02-05
Kenneth Block [OEM SYSTEMS CO. LTD.]
VARIANT II Hemoglobin Testing System2016-02-05
Kenneth Block [OEM SYSTEMS CO. LTD.]
iMark Microplate Reader2010-02-24

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